YY/T 1255-2015Immunoturbidimetry reagent (kit) (English PDF)
免疫比浊法检测试剂（盒）（透射法）
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 1255-2015 is the English-translated version of 免疫比浊法检测试剂（盒）（透射法）.
YY/T 1255-2015 is the Chinese pharmaceutical industry standard for the immunoturbidimetric reagent kit read in transmission, the general standard for reagents that measure an analyte by the turbidity of an antigen-antibody complex.
It specifies the terms and definitions, the requirements, the test methods, the marking, the labelling, the instructions and the rules for packaging, transport and storage, covering the appearance, the traceability of the calibrator, the accuracy, the linear range, the precision, the prozone effect and the stability. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 1255-2015
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements and test methods
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
1 Scope
This standard specifies the immunoturbidimetric assay reagent (kit) (transmission method) terms and definitions, requirements and test methods, marking, labeling, and so With instructions, packaging, transportation and storage.
This standard applies to transmission-based Immunoturbidimetry principle, the semi-automatic biochemical analyzer or other type of analyzer given Amount detection reagent (box).
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 21415 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrological traceability Derived
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 Immunoturbidimetry
In the reaction solution, and the antibody-antigen complex formed by precipitation, so that increase in turbidity. When light passes through the reaction solution, some of the light is like Product scattering some of the light is absorbed by the sample, the remaining light transmitted through the sample. The method of measuring the light absorption of the sample is immune nephelometry. Turbidimetric is Spectrophotometric determination Principle. In a fixed-angle scattered light scattering measurements turbidity (nephelometry).
Analyte concentration can be obtained by comparison with known concentration calibration solution is measured.
3.2 Blank limit
limitofblank; LoB Under certain probability, by a given measurement procedures measure up to the measurement results may be obtained blank sample. [CLSIEP17-A, 3]
4 Requirements and test methods
4.1 Appearance
Appearance should meet the following requirements.
a) the components of the kit should be complete, complete, no liquid leakage;
b) packaging label text symbols should be clear.
4.2 PACKING
Packed reagent amount not less than the indicated value.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
GB/T 21415-2008 — In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
GB/T 21415-2025 — In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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